- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407571
Echogenic Amniotic Fluid on Perinatal Outcome
Clinical Significance of Echogenic Amniotic Fluid on Perinatal Outcome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The sonographic appearance of amniotic fluid has been described as both anechoic and echogenic. The clinical significance of echogenic amniotic fluid remains undetermined. Increased echogenicity of the amniotic fluid may represent meconium. The presence of echogenic amniotic fluid at term on sonography is uncommon. The presence of meconium, blood or vernix caseosa in amniotic fluid may cause echogenicity.
The existence of meconium in amniotic fluid raises concerns about fetal well-being, the ability of the fetus to tolerate labor, or, most importantly, the risk of fetal/ neonatal demise . For these reasons, obstetricians tend to increase the frequency of prenatal visits to assess fetal well-being with non-stress tests or biophysical profiles (when there is no other indication for them), and even to induce labor when amniotic fluid is echogenic. On the other hand, elective induction of labor at term carries risks such as increased rate of cesarean section, uterine rupture or unexpected neonatal prematurity.
The presence of echogenic and dense particles in amniotic fluid on the ultrasound scan mimicking the view of a snow-storm in the third-trimester pregnant women is a cause of concern in antenatal management. that high-density intra-amniotic particles were possibly related to vernix caseosa, intra-amniotic bleeding, and meconium.
Although the most commonly reported cause of particulate or echogenic amniotic fluid was vernix caseosa, the reason for concern for the obstetricians in the case of intra-amniotic particles is its potential relationship with meconium as well as fetal compromise
. Free-floating dense particles in the amniotic fluid were also related to lung maturity and it was hypothesized that the source of these particles could be different in each trimester. The concerns for the presence of meconium-stained amniotic fluid in the case of an amniotic sludge may lead the obstetricians to elective induction in term pregnancies before the labor starts spontaneously which also increases the potential complications and caesarean rate
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Assiut, Egypt
- Al-Azhar University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women aged between 20, 35 years.
- Near or Full-term pregnant women admitted for delivery.
- Reliable date of LMP.
- Delivered vaginally after spontaneous onset of labor or CS.
Exclusion Criteria:
- Fetal congenital anomaly by ultrasound (anencephaly& Down syndrome), IUGR or macrosomic fetuses.
- Multifetal pregnancy.
- Maternal co-morbidity (Diabetes mellitus, hypertension, cardiac diseases, renal diseases & hemorrhagic diseases) .
- Maternal infection (Toxoplasmosis, Varicella zoster infection,…).
- Placental abnormality (abruption placenta & placenta previa)
- Cases with normal amniotic fluid study with ultrasonography.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Echogenic Amniotic Fluid
estimation the nature of echogenic amniotic fluid.to
overcome unnecessary intervention due to turbid amniotic fluid, assessing the neonatal outcome and estimation the gestational age at time of delivery in patients with echogenic amniotic fluid.
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To estimate the nature of echogenic amniotic fluid.and
To overcome unnecessary intervention due to turbid amniotic fluid, assess neonatal outcome and estimate gestational age at time of delivery in patients with echogenic amniotic fluid.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnant females with Echogenic Amniotic Fluid .
Time Frame: At the time of the Delivery
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Estimation the gestational age and neonatal status.
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At the time of the Delivery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Hanaa Ibrahim
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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